510(k) K922565 ยท GJS Test, Time, Prothrombin
NEOPLASTINE(R) CI KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Dec 7, 1992 |
| Received | Jun 1, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922565
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2018 | Diagnostica Stago, Inc. Diagnostica Stago STA Noplastine CI, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma.
REF: 00666
The STA - Noplastine CI kits provide reagents for the determ Terminated |
GJS | None listed |
| Oct 25, 2017 | Diagnostica Stago, Inc. STA - Neoplastine Cl (ref. 00605)
Product Usage:
Manual or automated determination of the prothrombin time (PT). Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.